Trillium Bio Disposable Blood Flow Probe (Models DP38T & FP38P)
FDA 510(k) K012747 · Medtronic Perfusion Systems
510(k) numberK012747
Submission
- Device name
- Trillium Bio Disposable Blood Flow Probe (Models DP38T & FP38P)
- Applicant
- Medtronic Perfusion Systems
Minneapolis, MN, US - Received
- August 16, 2001
- Decision date
- September 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPT – Probe, Blood-Flow, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2120
- Specialty
- Cardiovascular
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Questions and answers
When was Trillium Bio Disposable Blood Flow Probe (Models DP38T & FP38P) cleared by the FDA?
Trillium Bio Disposable Blood Flow Probe (Models DP38T & FP38P) (K012747) received a 510(k) decision of Substantially Equivalent on September 14, 2001, 29 days after the submission was received.
What is the product code of K012747?
The FDA product code is DPT – Probe, Blood-Flow, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2120.